Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep

Pharmacological Action Clinical Trial

Official title:

Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03904303
• Other study ID #: REG-014-2018
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Zealand University Hospital
• Contact: Hanne Holm, RN
• Phone: +4593567014
• Email: hanh[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy

Description:

Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.

Study performed in health subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Allergy to content of products

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• A 06 ad
Colonic cleansing before colonoscopy and CT colonografi

Locations

Country	Name	City	State
Denmark	Zuh	Køge	Region Of Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel preparation scale (BBPscale)	Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9.	Performed during the endoscopy procedure
Primary	Adverse events related to intervention	Any adverse event related to the intervention observed by investigators or as reported by the participant	Assessed 4 hours after last intake of cleansing product
Secondary	Blood pressure	mmHg systolic and diastolic measured on right or left arm.	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Secondary	Saturation	Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%.	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Secondary	Heart rate	Heart rate	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Secondary	Respiration frequency	Respiration frequency	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination